DK167267B1

DK167267B1 - EXTERNAL CATHETS FOR MEN COMBINED WITH LAYOUT

Info

Publication number: DK167267B1
Application number: DK129886A
Authority: DK
Inventors: Kenneth E Riedel; David L Doerschner
Original assignee: Hollister Inc
Priority date: 1985-03-21
Filing date: 1986-03-20
Publication date: 1993-10-04
Also published as: AU577184B2; KR930007904B1; GB2172506A; IT1191298B; DK129886D0; NL191078C; ES8707670A1; DE3609079A1; US4589874A; GB8606619D0; FR2579097A1; IE58503B1; AT393627B; CA1263830A; IT8647791A0; DE3609079C2; GB2172506B; ES553212A0; SE8601246L; JPS61220660A

Description

i DK 167267 B1in DK 167267 B1

Den foreliggende opfindelse angår et eksternt kateter til bortledning af urin for mænd kombineret med en applikator til at lette korrekt påsætning af kateteret på en patient. Kateteret omfatter en cylindrisk sektion oprullet til en torus, som understøttes af applikatoren, 5 før kateteret påsættes, en tilspidset halssektion, som rager igennem ap-plikatorens åbne ende, og en indvendig muffedel, som holdes i udstrakt tilstand af applikatoren for at hjælpe med til at sikre anbringelsen af muffen i tæt kontakt med patientens penisglans under det indledende trin af kateterpåsætningen.The present invention relates to an external catheter for draining urine for men combined with an applicator to facilitate proper application of the catheter to a patient. The catheter comprises a cylindrical section wound into a torus supported by the applicator prior to attaching the catheter, a tapered neck section projecting through the open end of the applicator, and an inner sleeve portion held in the extended state by the applicator to assist. ensuring the placement of the sleeve in close contact with the patient's penile lumen during the initial stage of the catheter application.

10 Brugen af eksterne katetere til afledning af urin for mænd er velkendt og er beskrevet i US patentskrifterne nr. 4.378.018, 4.187.851, 3.863.638, 3.835.857 og 4.475.910. En sådan indretning omfatter i det væsentlige et elastisk hylster indrettet til at passe omkring brugerens penis, idet hylsteret ved sin ydre ende har et udløb, som er forbundet 15 til et rør, der fører til en passende opsamlingsbeholder. Da lækage pga. tilbagestrømning af væske mellem penis og hylsteret naturligvis er uønsket, er det blevet en sædvanlig teknik at indskyde en tætningspude mellem hylsteret og penisskaftet, som det f.eks. er beskrevet i US patentskrift nr. 4.187.851 og nr. 4.378.018.The use of external urinary catheters for men is well known and is described in U.S. Patent Nos. 4,378,018, 4,187,851, 3,863,638, 3,835,857, and 4,475,910. Such a device essentially comprises an elastic casing arranged to fit around the user's penis, the casing having at its outer end an outlet which is connected to a tube leading to a suitable collecting container. Since leakage due to fluid flow between the penis and the sheath is naturally undesirable, it has become a conventional technique to insert a sealing pad between the sheath and the penis shaft, such as the are described in U.S. Patent Nos. 4,187,851 and 4,378,018.

20 Når tætningspuden anvendes korrekt, udfører den en dobbelt funktion med hensyn til forebyggelse af lækage og fastholdelse af kateteret, men der har vist sig vanskeligheder ved påsætningen af sådanne puder og katetere på brugerne nøjagtigt som ønsket. En pude af den type, som er afbildet i US patentskrift nr. 4.187.851, har f.eks. form af en klæbe-25 strimmel indrettet til at vikles omkring penisskaftet før det elastiske kateter afrulles til sin stilling over penis. Udførelsen af sådanne operationer kan være vanskelig eller umulig ved patienter, som lider af u-rininkontinens, idet sådanne patienter ofte mangler den for sådanne manipulationer nødvendige motoriske kontrol og/eller mentale klarhed. Sy-30 geplejersker eller andre plejere kan være ude af stand til at tage sig den fornødne tid til korrekt at omvikle og forme tætningspuderne i stilling og derpå omhyggeligt at sætte hylsteret over puderne for at danne lækagefri tætninger. Selvom der laves fejl, som kunne øge risikoen for efterfølgende lækage, kunne en sygeplejerske eller en plejer ikke desto 35 mindre efterlade den ikke korrekt påsatte pude og kateteret i stilling pga. manglende tid eller pga. af det ubehag for patienten, der kunne følge ved aftagning af de ikke korrekt påsatte puder og gentagelse af 2 DK 167267 B1 processen forfra. Endvidere kan problemerne, som resulterer fra ukorrekt påsætning af udstyret, være mere alvorlige end lejlighedsvis lækage af fluidum eller et mildt ubehag for patienten. Hvis en klæbende pude af den i US patentskrift nr. 4.187.851 beskrevne type således f.eks. vikles 5 for stramt omkring penisskaftet, kan omløbet hæmmes og der kan ske henfald af væv.20 When properly used, the sealing pad performs a dual function of preventing leakage and retaining the catheter, but difficulties in applying such pads and catheters to users have been found exactly as desired. For example, a pad of the type depicted in U.S. Patent No. 4,187,851 has. in the form of an adhesive strip arranged to wrap around the penis shaft before the elastic catheter is unwound to its position over the penis. The performance of such operations may be difficult or impossible in patients suffering from urinary incontinence, such patients often lacking the motor control and / or mental clarity required for such manipulations. Sewing-30 nurses or other caregivers may be unable to take the necessary time to properly wrap and mold the sealing pads into position and then carefully place the sheath over the pads to form leak-free seals. Even though mistakes are being made that could increase the risk of subsequent leakage, a nurse or a nurse could nevertheless leave the improperly placed cushion and catheter in position due to lack of time or due to the patient's discomfort that could follow. removing the incorrectly installed pads and repeating the process from the front. Furthermore, the problems resulting from improper application of the equipment may be more severe than occasional fluid leakage or mild discomfort to the patient. Thus, if an adhesive pad of the type disclosed in U.S. Patent No. 4,187,851, e.g. wound 5 too tightly around the penis shaft, the circulation may be inhibited and tissue decay may occur.

Der kendes eksterne katetere, som er indvendigt belagt med trykfølsomt klæbestof og derfor eliminerer behovet for anvendelse af separate klæbestofbel agte tætningspuder som vist f.eks. i US patentskrift nr.External catheters are known which are internally coated with pressure-sensitive adhesive and therefore eliminate the need for the use of separate adhesive bubble-like sealing pads as shown e.g. in U.S. Pat.

10 4.475.910. Omend en sådan konstruktion undgår nogle af de mere alvorlige risici, som følger med tætningspuder til omvikling, består der stadig vanskeligheder ved påsætningen og problemer ved lækage pga. ukorrekt påsætning, og de kan endda være endnu mere udtalte. Der må ofres betydelig omhu, når det klæbestofbel agte hylster rulles ud over penis for at sik-15 re, at hylsteret påsættes jævnt uden at udvikle folder og strømningskanaler. Alt for ofte kommer de klæbestofbel agte indre overflader af et sådant hylster i indbyrdes kontakt under påsætningen af kateteret. Adskillelsen af de overflader, der kommer i kontakt med hinanden, er, hvis den da overhovedet er mulig, vanskelig og tidskrævende med det resultat, 20 at afhjælpende foranstaltninger måske udelades, og lækage af kateteret ved senere brug praktisk taget er givet.10 4,475,910. Although such a construction avoids some of the more serious risks that come with sealing pads for wrapping, difficulties in application and leakage problems due to improper application remain, and they may be even more pronounced. Substantial care must be sacrificed when the adhesive-like casing is rolled out over the penis to ensure that the casing is applied evenly without developing folds and flow channels. Too often, the adhesive bubble-like inner surfaces of such a casing come into contact with each other during the application of the catheter. The separation of the surfaces that come into contact with each other is, if at all possible, difficult and time-consuming, with the result that corrective measures may be omitted and leakage of the catheter for later use is practically given.

En verserende US patentansøgning nr. 613.279 med indleveringsdag 24. maj 1984 beskriver et eksternt kateter for mænd med en indvendig muffe indrettet til at strækkes omkring penisglans for at forhindre bag-25 udstrømning og beskytte den sarte hud på glans fra beskadigelser pga. vedvarende kontakt med tilbageværende urin, som kan stå nær hylsterets udløbsende under kateterets brug, navnlig ved en sengeliggende patient.A pending U.S. Patent Application No. 613,279, filed May 24, 1984, discloses an external male catheter with an internal sleeve arranged to extend around penile luster to prevent posterior outflow and protect the delicate skin from glare from damage due to sustained contact with residual urine, which may stand near the outlet end of the sheath during use of the catheter, especially in a bedridden patient.

Et lignende kateter med en indvendig muffe er også beskrevet i en verserende US patentansøgning nr. 510.904, indleveret 5. juli 1983. Hvadenten 30 et sådant kateter holdes på plads af klæbende belægning eller af en klæbende pude kræver det for korrekt operation, at den indre muffe udstrækkes til fluidumtæt forseglende kontakt med glans, før den indre cylindriske del af kateteret fæstnes med klæbestof til penisskaftet.A similar catheter with an internal sleeve is also disclosed in a pending U.S. Patent Application No. 510,904, filed July 5, 1983. Whether such a catheter is held in place by adhesive coating or an adhesive pad requires proper operation for the internal sleeve is extended to fluid tight sealing contact with gloss before the inner cylindrical portion of the catheter is attached with adhesive to the penis shaft.

Andre kendte patentskrifter på området er svensk patentskrift nr.Other known patents in the field are Swedish Patent Specification no.

35 162302 og US patentskrifterne nr. 4.022.213, 4.284.079, 3.405.714, 4.239.044, 3.353.538, 3.511.241, 3.721.243, 3.631.857, 3.788.324, 3.339.551, 3.364.932, 4.296.502 og 3.742,953.U.S. Patent Nos. 3,162,302 and U.S. Patent Nos. 4,022,213, 4,284,079, 3,405,714, 4,239,044, 3,353,538, 3,511,241, 3,721,243, 3,631,857, 3,788,324, 3,339,551, 3,364,932. , 4,296,502 and 3,742,953.

3 DK 167267 B13 DK 167267 B1

Den foreliggende opfindelse tilvejebringer en kombination af et kateter og en applikator, som undgår de ovennævnte ulemper. Dette opnås ved en kateter/applikatorkombination, hvori det eksterne kateter er beregnet til at fastholdes fastklæbet på penis, fortrinsvis ved en belæg-5 ning af trykfølsomt klæbestof, som er påført kateterets indre overflade under fremstillingen, og med en indbygget indre muffe indrettet til at strækkes over og sidde tæt omkring penisglans for at beskytte huden på glans og frembringe et ekspanderbart rum mellem den indre muffe og det ydre hylster for at kunne rumme bølger af fluidum og forhindre bagud-10 strømning af fluidum, som, hvis ikke den indre muffe var til stede, kunne angribe den klæbende forbindelse mellem kateteret og penisskaftet. Applikatoren samvirker med kateteret for at lette korrekt orientering af den indre muffe i forhold til glans på det tidspunkt, kateteret sættes på. Hermed elimineres eller reduceres risikoen for, at kateteret eventu-15 elt skulle blive påsat ukorrekt på en patient, betydeligt.The present invention provides a combination of a catheter and an applicator which avoids the above disadvantages. This is achieved by a catheter / applicator combination in which the external catheter is intended to be retained on the penis, preferably by a coating of pressure sensitive adhesive applied to the inner surface of the catheter during manufacture, and with a built-in internal sleeve adapted to is stretched over and seated tightly around the penis luster to protect the skin from shine and to create an expandable space between the inner sleeve and outer sheath to accommodate fluid waves and prevent backward flow of fluid which, if not the inner sleeve was present, could attack the adhesive connection between the catheter and penis shaft. The applicator interacts with the catheter to facilitate proper orientation of the inner sleeve relative to the luster at the time the catheter is inserted. This significantly eliminates or reduces the risk that the catheter may be incorrectly applied to a patient.

Det i denne kombination anvendte eksterne kateter har form af et hylster af tyndt, strækbart, elastisk materiale med en stort set cylindrisk sektion, som i den ene ende går over i en tilspidset halssektion, der slutter i en udløbssektion med indsnævret diameter, og en indre muf-20 fe med en indre ende, som går over i den cylindriske sektions yderste ende, samt en aflang, tilspidset ydre ende, som går ind i halssektionen og slutter i en ydre åbning i afstand fra udløbssektionen. Et sådant kateter er vist og beskrevet i den ovennævnte verserende ansøgning nr.The external catheter used in this combination is in the form of a sleeve of thin, stretchable, elastic material having a substantially cylindrical section, which at one end becomes a tapered neck section terminating in an outlet section with a narrow diameter, and an inner sleeve with an inner end extending into the outer end of the cylindrical section, and an elongated, tapered outer end which enters the throat section and terminates in an outer opening at a distance from the outlet section. Such a catheter is shown and described in the above pending application no.

613.279 indleveret 24. maj 1984.613,279 filed May 24, 1984.

25 Applikatoren har form af en relativt stiv krave med åben ende udformet af polyethylen eller et andet passende formstofmateriale. Kraven har ved sin ene ende en ekstern omkransende vulst. Ved eller nær sin modsatte ende har kraven et par af diametralt modsatte recesser, som er store nok til at passe til brugerens fingre, når kateteret sættes på en 30 patient. Når delene kombineres, har kateteret sin cylindriske sektion oprullet til en torus, som strækker sig omkring og fastholdes af kraven, idet kravens vulst tjener som fastholdeorgan. Kateterets hals- og udløbssektioner rager fremad igennem kravens åbning, og den indre muffe rager ud fra torussen over kravens vulst og derpå radialt indad ved kra-35 vens indre ende. Den radialt indad strakte del af den indre muffe fastholdes i udstrakt og stort set plan tilstand langs et plan, som er vinkelret på kravens centrale akse.The applicator is in the form of a relatively rigid open end collar formed of polyethylene or other suitable resin material. The collar has at one end an external encircling bead. At or near its opposite end, the collar has a pair of diametrically opposed recesses large enough to fit the user's fingers when the catheter is inserted on a patient. When the parts are combined, the catheter has its cylindrical section wound into a torus which extends and is retained by the collar, the bead of the collar serving as a retaining member. The neck and outlet sections of the catheter project forwardly through the opening of the collar, and the inner sleeve protrudes from the torus over the bead of the collar and then radially inward at the inner end of the collar. The radially inwardly extending portion of the inner sleeve is held in an extended and substantially planar state along a plane perpendicular to the central axis of the claim.

4 DK 167267 B14 DK 167267 B1

Den af kateterets oprullede cylindriske sektion formede torus har en indre diameter, som er mindre end vulstens ydre diameter og vulsten holder derfor torussen fast på kraven, indtil der påføres en aksi al af-rulningskraft på torussen af en størrelse, som er tilstrækkelig til at 5 udstrække eller ekspandere torussen udad og tillade den at rulle af ud over vulsten.The torus formed by the coiled cylindrical section of the catheter has an inner diameter smaller than the outer diameter of the bead, and the bead therefore holds the torus to the collar until an axial unwinding force is applied to the torus of a size sufficient to extend or expand the torus outward and allow it to roll off beyond the bead.

Under brugen gribes kateter/applikatorkombinationen med fingrene på én hånd for at rette kateterets udstrakte indre hylster mod penisglans. Eftersom kraven skydes frem til at omslutte glans, vikles den udstrakte 10 hylsterdel omkring glans, idet den følger dens kontur og lægger sig tæt mod dens overflade. Mens hylsteret lægger sig tæt om glans, holder brugeren samtidig kateterets krave- og halsdel fast i forhold til glans (denne operation lettes betydeligt ved de diametralt modsat anbragte fingerrecesser, som er udformet i kraven) og ruller derpå ved at bruge 15 fingrene på den anden hånd torussen over kravens vulst og langs med pe-nisskaftet.During use, the catheter / applicator combination is gripped with the fingers of one hand to direct the catheter's extended inner sheath to penile luster. As the collar is pushed forward to enclose gloss, the extended 10 sleeve portion is wrapped around gloss as it follows its contour and lays close to its surface. While the sheath sits tightly around the gloss, the user simultaneously holds the catheter collar and neck portion relative to the glans (this operation is greatly facilitated by the diametrically opposite finger recesses formed in the collar) and then rolls using the 15 fingers of the other hand the torus over the collar bead and along the penis shaft.

Yderligere ejendommeligheder, fordele og formål med opfindelsen vil fremgå af den følgende detaljerede beskrivelse og tegningen, hvorpå: 20 figur 1 er et perspektivisk billede af en kombination af et kateter og en applikator, som er klar til brug til påsætning af det eksterne kateter på et mandslem, figur 2 et perspektivisk billede, som viser applikatoren alene, figur 3 er et delvist perspektivisk billede visende kombinationen 25 af applikator og krave, som den vil se ud fra sin indre ende, figur 4 er et planbiIlede vist delvist gennemskåret af et kateter af den type, som anvendes i kombinationen ifølge opfindelsen, figur 5 er et snitbillede, som viser kombinationen af kateter og applikator, som den leveres til en bruger, 30 figur 6 er et snitbillede svarende til figur 5, men visende første trin i påsætningen af kateteret på en patient, figur 7 svarer til figur 6, men viser følgende trin i påsætningen af kateteret, og figur 8 er et forstørret detaljebiIlede af en del fra figur 5.Further features, advantages and objects of the invention will become apparent from the following detailed description and drawings, in which: Figure 1 is a perspective view of a combination of a catheter and an applicator ready for use in attaching the external catheter to a Figure 2 is a perspective view showing the applicator alone; Figure 3 is a partial perspective view showing the combination 25 of the applicator and collar as it will appear from its inner end; Figure 4 is a plan view partially cut through a catheter of Fig. 5 is a sectional view showing the combination of catheter and applicator supplied to a user; Fig. 6 is a sectional view similar to Fig. 5, but showing the first step in the application of the catheter. in a patient, Figure 7 corresponds to Figure 6, but shows the following steps in the application of the catheter, and Figure 8 is an enlarged detail image of a portion of the catheter. Figure 5.

Det eksterne urinafledningskateter for mænd, som udgør det ene element af opfindelsens to-element-kombination, indebefatter de i verseren- 35 5 DK 167267 B1 de US patentansøgning nr. 613.279 beskrevne ejendommeligheder. Et sådant eksternt kateter 10 vises mest tydeligt i ikke sammenrullet tilstand i figur 4. Det er udformet af blødt, meget elastisk naturligt eller syntetisk gummi. Der foretrækkes naturligt latex, men der kan anvendes andre 5 elastomerer med lignende egenskaber. Kateteret indeholder et aflangt ydre hylster 11 og en indre muffe 12, idet de to er ud i ét med hinanden eller permanent samlet som beskrevet i det følgende.The male external urinary diversion catheter, which constitutes one element of the two-element combination of the invention, includes the properties described in U.S. Patent Application No. 613,279. Such an external catheter 10 is most clearly shown in the unrolled state of Figure 4. It is formed of soft, very elastic natural or synthetic rubber. Natural latex is preferred, but other elastomers with similar properties can be used. The catheter contains an elongated outer sheath 11 and an inner sleeve 12, the two being integrally or permanently assembled as described below.

Det ydre hylster 11 har en aflang cylindrisk sektion 11a, en indsnævret drænrørssektion 11b og en tilspidset halssektion 11c anbragt 10 derimellem. Den cylindriske sektions 11a vægtykkelse er tydeligt mindre end den for hals- og drænrørssektionerne. Den cylindriske sektion kan f. eks. have en vægtykkelse i almindelighed inden for området af 0,15 til 0,25 mm (0,006 til 0,10") og er i almindelighed for tynd eller blød til at holde en cylindrisk form uden støtte. Drænrørs- og halssektionerne 15 kan derimod have en tykkelse på 1,25 mm (0,050") eller mere og er i almindelighed kraftige nok til, at sådanne sektioner vil opretholde de viste konfigurationer, når de ikke påvirkes af andre kræfter, og vil fjedre tilbage til de viste former, når påvirkningskræfter tages væk.The outer casing 11 has an elongated cylindrical section 11a, a narrowed drainage section 11b and a tapered neck section 11c disposed therebetween. The wall thickness of the cylindrical section 11a is clearly smaller than that of the neck and drainage sections. For example, the cylindrical section may have a wall thickness generally in the range of 0.15 to 0.25 mm (0.006 to 0.10 ") and is generally too thin or soft to hold a cylindrical shape without support. The drainage and throat sections 15, on the other hand, can have a thickness of 1.25 mm (0.050 ") or more and are generally strong enough that such sections will maintain the configurations shown when not affected by other forces and will spring back to the forms shown when forces of influence are taken away.

Halssektionen Uc har i sin forreste eller yderste ende en afrundet 20 spidsning, der fører til en indsnævret åbning 13. Endvidere har halssektionen flere vindinger eller kransformede forstørrelser 14. Der er vist to sådanne vindinger med gradueret størrelse, idet deres formål er at tillade øget strækbarhed, bøjning og vridning af drænrørs- og halsdelene, når indretningen anvendes, og det med mindre tilbøjelighed til sam-25 mensnøring eller blokering af lysningen. Endvidere forøger sådanne vindinger fluidumrumfanget ved halssektionens ydre ende og tilvejebringer et reservoir til at rumme bølger af fluidum under indretningens brug.The neck section Uc has at its front or outer end a rounded 20 leading to a narrowed opening 13. In addition, the neck section has several turns or wreath-shaped enlargements 14. Two such turns of graduated size are shown, their purpose being to allow increased stretchability. , bending and twisting of the drainage and neck portions when the device is used, and that with less inclination to constrict or block the groove. Furthermore, such turns increase the volume of fluid at the outer end of the neck section and provide a reservoir for accommodating waves of fluid during use of the device.

Indermuffen 12 har en inderste endedel 12a, som går blødt over i yderenden af yderhylsterets cylindriske kropsdel 11a, og en aflang ydre 30 endedel 12b anbragt inden for yderhylsterets halssektion 11c. Den yderste endedel 12b spidser fremad og indad og slutter i en indsnævret ydre åbning 15, som ligger i en klar afstand bag ved (dvs. inden for) åbningen 13. Denne afstand bevirker også tilvejebringelsen af et kransformet og aksialt langstrakt ekspansionsrum 16 mellem yderfladen af indermuf-35 fens yderste endedel 12b og inderfladen af halssektionen 11c. Indermuf-fens vægtykkelse kan varieres, men for at sikre tilpasningsevne, gode tætningsegenskaber og brugerkomfort bør denne tykkelse svare til den af 6 DK 167267 B1 den relativt tynde cylindriske kropssektion 11a. Både den cylindriske kropssektion 11a og indermuffen 12b skulle således fremtræde som tynde, bløde og meget strækbare membraner i modsætning til drænrørs- og halssektionerne 11b og 11c, som har formfastholdende egenskaber.The inner sleeve 12 has an inner end portion 12a which softens into the outer end of the cylindrical body portion 11a of the outer casing, and an elongated outer end portion 12b located within the neck section 11c of the outer casing. The outer end portion 12b projects forward and inward and terminates in a narrowed outer aperture 15 which is at a clear distance behind (i.e., within) the aperture 13. This distance also provides the provision of a corrugated and axially elongated expansion space 16 between the outer surface of the the outer end portion 12b of the inner sleeve and the inner surface of the neck section 11c. The wall thickness of the inner sleeve may be varied, but to ensure adaptability, good sealing properties and user comfort, this thickness should correspond to that of the relatively thin cylindrical body section 11a. Thus, both the cylindrical body section 11a and the inner sleeve 12b were to appear as thin, soft and highly extensible membranes, in contrast to the drainage tube and throat sections 11b and 11c, which have mold retaining properties.

5 Klæbemidlet til klæbefastgøring af kateteret til penisskaftet kan have form af en separat klæbepude, som påsættes før kateteret sættes på en bærer, eller det kan alternativt have form af en klæbende belægning på inderfladen af kateterets cylindriske sektion 11a. Begge former er fuldt beskrevne i ovennævnte verserende US patentansøgning nr. 613.279, 10 omend kun den sidstnævnte udførelsesform er vist i nærværende skrift i figur 4. Den klæbende zone 17 findes inden i yderhylsterets cylindriske sektion 11a bag indermuffen 12. Omend den klæbende belægning kunne tænkes at udstrække sig over den cylindriske sektions 11a fulde længde, foretrækkes det at tilvejebringe den klæbende zone i form af et smalt, men 15 kontinuert bånd placeret inden i yderenden af yderhylsterets cylindriske sektion 11a. Klæbebelægningen kan være opbygget af ethvert egnet medicinsk trykfølsomt klæbestof af en type, som kendes på området, et hypo-allergenisk acrylklæbestof skønnes at være særligt fordelagtigt.The adhesive for affixing the catheter to the penis shaft may be in the form of a separate adhesive pad which is affixed before the catheter is affixed to a carrier, or alternatively it may take the form of an adhesive coating on the inner surface of the cylindrical section 11a of the catheter. Both forms are fully described in the above pending U.S. Patent Application No. 613,279,10, although only the latter embodiment is shown in the present disclosure in Figure 4. The adhesive zone 17 is located within the cylindrical section 11a of the inner sleeve 12. Although the adhesive coating could be conceivable. to extend over the full length of the cylindrical section 11a, it is preferred to provide the adhesive zone in the form of a narrow but continuous band located within the outer end of the cylindrical section 11a of the outer casing. The adhesive coating may be made up of any suitable medical pressure sensitive adhesive of a type known in the art, a hypoallergenic acrylic adhesive deemed to be particularly advantageous.

Applikatoren har form af et kort rør eller en krave 20, som det 20 mest tydeligt ses i figurerne 2 og 5-8. Den korte krave 20 med åben ende er i almindelighed cylindrisk udformet, omend den foretrukne udførelses-form som vist på tegningen har en svag spidsning. Kraven kan bestå af ethvert af et stort udvalg af relativt stive eller faste formstofm'ateri-aler. Et polyolefin såsom højtæthedspolyethylen skønnes særligt fordel-25 agtigt, men andre polymeriske materialer med lignende egenskaber ville også være velegnede. Der kunne også anvendes ikke-polymeriske materialer såsom f.eks. pap.The applicator is in the form of a short tube or collar 20, as most clearly seen in Figures 2 and 5-8. The short open collar 20 is generally cylindrical in shape, although the preferred embodiment as shown in the drawing has a slight tip. The collar may comprise any of a wide variety of relatively rigid or solid plastics materials. A polyolefin such as high density polyethylene is particularly advantageous, but other polymeric materials with similar properties would also be suitable. Non-polymeric materials such as e.g. cardboard.

Kraven er forsynet med en blødt afrundet ydre forstørrelse eller vulst 21 ved sin i nderende. Ved sin modsatte eller yderste ende er in-30 deroverf1 aden skrå eller buet som vist ved 22. Et par af forstørrede recesser er udformet i kravens cylindriske væg, idet sådanne recesser er diametralt modstående og fortrinsvis buet udformet. Når kraven ses i si-debillede har hver reces mere specifikt stort set halv-cirkulær form med åbningen mod kravens yderende. Hver reces har en aksi al udstrækning, som 35 er omtrent det halve af kravens længde, og længden af selve kraven er mindre end kravens diameter og betydeligt mindre end længden af kateterets halssektion 11c.The collar is provided with a soft rounded exterior enlargement or bead 21 at its bottom. At its opposite or extreme end, the interior surface is inclined or curved as shown at 22. A pair of enlarged recesses are formed in the cylindrical wall of the claim, such recesses being diametrically opposed and preferably curved. More specifically, when the collar is seen in si-debilled, each recess has substantially semi-circular shape with the opening towards the outer edge of the collar. Each recess has an axial extension which is about half the length of the collar and the length of the collar itself is less than the diameter of the collar and significantly less than the length of the catheter neck section 11c.

7 DK 167267 B17 DK 167267 B1

Kateteret og kraven leveres til brugeren med kateteret sat på kraven som vist i figurerne 1, 3, 5 og 8. Kateterets cylindriske sektion 11a er sammenrullet, så den danner en torus 25. Kraven 20 er dimensioneret således, at dens yderdiameter bortset fra vulsten 21 er omtrent den 5 samme som eller en lille smule større end torussens 25 indvendige diame ter. Vulsten 21 har derfor en yderdiameter, som er markant større end torussens inderdiameter med det resultat, at vulsten tjener som et fastholdeorgan til at holde torussen på plads, indtil der påføres en tilstrækkelig stor aksial udrullekraft på torussen, til at den kan udstræk-10 kes eller ekspanderes for at gå over vulsten.The catheter and collar are delivered to the user with the catheter attached to the collar as shown in Figures 1, 3, 5 and 8. The catheter section 11a of the catheter is rolled up to form a torus 25. The collar 20 is dimensioned so that its outer diameter except the bead 21 is about the same as or slightly larger than the inner diameter of the torus 25. The bead 21 therefore has an outer diameter which is significantly larger than the inner diameter of the torus, with the result that the bead serves as a retaining means to hold the torus in place until a sufficiently large axial rolling force is applied to the torus to extend it. or expanded to go over the bead.

Halssektionen 11c udstrækker sig fra torussen 25 indad omkring vulsten 21 og derpå fremad eller udad gennem kravens 20 åbning. Den kor-rugerede del 14 ligger helt fri uden for kravens yderende og ligeså kateterets udløbssektion 11b.The neck section 11c extends from the torus 25 inwardly around the bead 21 and then forward or outward through the opening of the collar 20. The corrugated portion 14 is completely free outside the outermost end of the claim and likewise the outlet section 11b of the catheter.

15 Det er særlig vigtigt, at indermuffen 12 fastholdes i strakt eller spændt tilstand ved kravens 20 i nderende. Indermuffen udstrækker sig fra torussen 25 omkring vulsten 21 og derpå radialt indad langs et plan, som er vinkelret på kravens akse (figurerne 3, 5 og 8). Bortset fra den centrale åbning 15 fremtræder indermuffen derfor som en membran udstrakt 20 hen over kravens inderende. Vulsten 21 udfører derfor en dobbelt funktion, idet den forhindrer torussen 25 i at rulle ud og dels pga. denne fastholdelse holder indermuffen i den viste udstrakte og stort set plane tilstand.It is particularly important that the inner sleeve 12 be held in a stretched or tensioned condition at the end of the claim 20. The inner sleeve extends from the torus 25 about the bead 21 and then radially inwards along a plane perpendicular to the axis of the collar (Figures 3, 5 and 8). Therefore, apart from the central opening 15, the inner sleeve appears as a membrane extending 20 over the inner end of the collar. The bead 21 therefore performs a dual function, preventing the torus 25 from rolling out and partly because of this retention, the inner sleeve holds in the shown extended and substantially planar state.

Det fremgår af figur 8, at det klæbende lag eller zone 17 er place-25 ret tilstrækkelig langt fra overgangen mellem indermuffen 12 og halsdelen 11c til at torussens yderste flader ikke har klæbende belægning. Der er således ingen fare for, at klæbestoffet 17 kunne hæfte til inderfla-derne af en pose eller indpakning (ikke vist) såsom en, hvori aggregatet markedsføres og opmagasineres. Selvom kateterets cylindriske sektion er 30 oprullet til torusform klæber klæbestoffet ikke til yderfladen (når den rulles af) af den cylindriske sektion 11a takket være en slipbelægning eller et lag af siliconegummi eller andet egnet slipmateriale eller pga. en aftagelig strimmel eller et lag, som er kendt inden for teknikken, med det formål at forhindre utilsigtet sammenhæftning mellem trykfølsom-35 me klæbestoffer og derimod beliggende flader.It can be seen from Figure 8 that the adhesive layer or zone 17 is positioned sufficiently far from the junction between the inner sleeve 12 and the neck portion 11c that the outer surfaces of the torus do not have adhesive coating. Thus, there is no danger that the adhesive 17 could adhere to the inner surfaces of a bag or package (not shown) such as one in which the assembly is marketed and stored. Although the cylindrical section of the catheter is coiled in torus form, the adhesive does not adhere to the outer surface (when rolled off) of the cylindrical section 11a due to a release coating or a layer of silicone rubber or other suitable release material or due to a removable strip or layer which is known in the art, for the purpose of preventing accidental adhesion between pressure-sensitive adhesives and adjacent surfaces.

Figurerne 1 og 6-7 viser fremgangsmåden til påsætning af det eksterne kateter på en patient. Brugeren griber først den fritliggende ydre 8 DK 167267 B1 ende af kraven og fører den udstrakte membranagtige indermuffe 12 til berøring med glans (figur 6). Idet indermuffen er i udstrakt tilstand, kan den påsættes ligeligt og jævnt på glans. Når glans først er helt omsluttet af kravens 20 åbning, og muffedelen 12 er fuldt udstrakt over 5 glans i fast, tæt berøring hermed, griber brugeren halsdelen 11c og holder den fast mod glans, som det mest tydeligt er vist i figur 1. Denne } operation er betydeligt lettet takket være de store recesser 23, som fungerer som fingeråbninger under gribningen af kateterets halsdel 11c og glans 6 og til at fastholde kraven, når brugeren med fingrene på den 10 anden hånd presser torussen 25 bagud og ud over vulsten 21 (figur 7).Figures 1 and 6-7 show the procedure for attaching the external catheter to a patient. The user first engages the exposed outer end of the collar and guides the extended diaphragm-like inner sleeve 12 to the gloss (Figure 6). Since the inner sleeve is extended, it can be applied evenly and evenly to the gloss. Once the gloss is completely enclosed by the opening of the claim 20 and the sleeve portion 12 is fully extended over the 5 gloss in firm, close contact therewith, the user grabs the neck portion 11c and holds it against the gloss as most clearly shown in Figure 1. This} surgery is greatly facilitated thanks to the large recesses 23, which act as finger openings during the gripping of the catheter neck portion 11c and gloss 6 and to retain the collar as the user with the fingers of the other hand presses the torus 25 backwards and beyond the bead 21 (Figure 7).

Eftersom torussen rulles ud, bringes det klæbende lag 17 til berøring med penisskaftet S bag corona på glans, idet denne klæbende berøring herved fastholder det eksterne kateter i funktionsdygtig stilling med indermuffen 12 udstrakt over glans som vist i figur 7. Torussen afrulles 15 langs med penisskaftet som vist med punkterede streger i figur 7, kraven 20 aftages og fjernes og kateterets udløbssektion 11b forbindes til et passende drænrør (ikke vist).As the torus is rolled out, the adhesive layer 17 is brought into contact with the shaft of the penis S behind the corona, this adhesive touch thereby retaining the external catheter in operable position with the inner sleeve 12 extended over the gloss as shown in Figure 7. The torus is rolled 15 along the penis shaft as shown by dashed lines in Figure 7, the collar 20 is removed and removed and the catheter outlet section 11b connected to a suitable drainage tube (not shown).

Claims

An applicator with an external catheter (10) comprising a sleeve (11) of thin, stretchable, elastic material having a substantially cylindrical section (11a), which at one end passes into a tapered neck section ( 11c) terminating in an outlet section (11b) of narrowed diameter, and an inner sleeve (12) having one end extending into the outer end of the cylindrical section and an elongated, tapered outer end 10 (15) entering in the neck section and terminating in an outer opening (13) at a distance from the outlet section, the applicator comprising a relatively rigid and substantially cylindrical collar (20) with an open inner and an open outer and an outer annular bead (21) with soft rounded surfaces at its inner end, characterized in that the applicator and the external catheter are arranged in such a way that they can be combined so that the catheter (10) has its neck section (11c) extending through the collar (20), its outlet section (11b) ) projecting axi all from the requirement (20) y then, its cylindrical section (11a) wound into a torus (25) extending about the collar (20) in the immediate vicinity of the bead (21), and its inner sleeve 20 (12) extending from the torus (25) beyond the bead (21). ) and radially inwardly at the inner end of the collar (20), the radially inwardly extending portion of the inner sleeve being extended and substantially disposed in a plane perpendicular to the axis of the collar (20), the torus (25) having a non-stretched state. an inner diameter smaller than the outer diameter of the bead (21) in such a way that the bead (21) retains the torus (25) on the collar until a roll-off force is applied to the torus (25) of a size sufficient to expand its internal diameter.

Combination according to claim 1, characterized in that the collar (20) has a length less than the length of the catheter's neck section (11c).

Combination according to claim 2, characterized in that the collar (20) has an axial length which is considerably greater than the axial length of the torus (25). 35

4. A combination according to claim 1, 2 or 3, characterized in that the collar (20) is provided with a pair of diametrically opposed recesses (23) at its outer end, which fits a user's fingers when holding the neck section (11c) of the catheter and the collar (20) relative to the penis shine, and the torus (25) is rolled over the bead (21) and along the penis shaft.

A combination according to claim 4, characterized in that each of the recesses (23) is curved.

Combination according to claim 5, characterized in that each of the recesses (23) has an axial length which is about half the length of the claim (20). 10

Combination according to claim 1, characterized in that the collar (20) has a diameter greater than its length.

8. A combination according to claim 1, characterized in that the collar (20) is made of polyolefin.

9. A combination according to claim 8, characterized in that the polyolefin is high density polyethylene.

9 DK 167267 Bl

Combination according to claim 1, characterized in that the cylindrical section (11a) of the catheter has a circumferential coating (17) of pressure-sensitive adhesive in addition to at least part of the length, which coating of adhesive is arranged on the side of the cylindrical section. (11a) which touch the penile shaft as the catheter (10) is worn. 25

An applicator for attaching an external male urinary catheter comprising a relatively rigid and substantially cylindrical collar (20) with an open end and an open end, and an outer annular bead (21) with soft rounded surfaces at its inner end, 30, in that it is dimensioned such that a catheter (10) comprising a sleeve (11) of thin, stretchable, elastic material having a substantially cylindrical section (11a) which at one end passes into a tapered neck section (11c) terminating in an outlet section (11b) of narrow diameter, and an inner sleeve 35 (12) with an inner end extending into the outer surface of the cylindrical section and an elongated, tapered outer end (15), which enters the neck section and terminates in an outer opening (13) at a distance from the outlet section, may be arranged with its neck section (11c) extending through the collar (20), its outlet section (11b) projecting axially from the collar (11). 20) outer, its cylindrical a section (11a) wound into a torus (25) extending 5 around the collar (20) in the immediate vicinity of the bead (21), and an inner sleeve (12) extending from the torus (25) beyond the bead (25). 21) and radially inwardly at the end of the collar (20), the radially inwardly extending portion of the inner sleeve being extended and substantially disposed in a plane perpendicular to the axis of the collar (20), the torus (25) having an unstretched state 10 an inner diameter smaller than the outer diameter of the bead (21) in such a way that the bead (21) retains the torus (25) on the collar until a roll-off force is applied to the torus (25) of a size sufficient to expand its inside diameter.

12. Applicator according to claim 11, characterized in that the collar (20) is provided with a pair of diametrically opposed recesses (23) which fit a user's fingers as they hold the neck section (11c) and the collar (20) in relation to the penis shine, and the torus (25) is rolled over the bead (21) and along the penis shaft. 20

Applicator according to claim 12, characterized in that each of the recesses (23) is curved.

Applicator according to claim 12 or 13, characterized in that each 25 of the recesses (23) has an axial length which is about half the length of the claim (20).

An applicator according to claims 11-14, characterized in that the collar (20) has a diameter greater than its length. 30

Applicator according to claims 11-15, characterized in that the collar (20) is formed of polyolefin. DK 167267 B1 12

The applicator according to claim 16, characterized in that the polyolefin is high density polyethylene.